FDA Implements Rapid REMS

FDA aims to make its risk evaluation and mitigation strategy easier, and changes are in the works to help manufacturers meet the required safety measures

By Katie Weiler, Managing Editor

When I think of REMS, I immediately think of rapid eye movement sleep - what we all dream of having every night! But as I get older, my mind doesn’t seem to shut down as easily, and I find myself staring at the ceiling and cursing my alarm clock when it goes off as the sun rises.

So when I saw an FDA blogger talking about REMS, it piqued my interest that maybe the agency approved a new sleep remedy or non-habit-forming medication to help my predicament. But no such luck. Instead, it was referring to its risk evaluation and mitigation strategy (REMS), which applies to certain FDA-approved drugs that require drug manufacturers to outline specific safety steps to be taken before a patient can be given the medications.

Drug companies develop REMS programs - which involve the patient, healthcare providers and manufacturers - and then the FDA reviews and approves them. The plans are designed to help ensure that the benefits of a prescription drug outweigh its risks. For example, if a drug could potentially cause birth defects, a REMS program might require that a patient be asked her pregnancy status before beginning that drug.

The Agency can request a REMS from the manufacturer both before and after a drug is approved. According to Theresa Toigo, MBA, RPh, associate director for Drug Safety Operations in the FDA’s CDER, each REMS program is unique and targets a specific risk or risks associated with a particular drug or drug class.

“Depending on the risk or risks involved, a REMS program could include a range of requirements such as providing a patient or healthcare professional with an information sheet, enrolling a patient in a registry prior to taking the drug, requiring special training for a prescriber, or requiring that a patient’s lab values be reviewed before he or she can be given the drug,” Toigo said.

As with other FDA regulations, REMS requirements have raised concerns about clinical and administrative burdens placed on healthcare professionals, as well as concerns that those requirements could delay a patient’s course of treatment.
So what is the FDA doing to address those concerns and ease the burdens? Toigo shared an update:

• FDA revised the draft recommendations on the format and content of REMS documents. The revised REMS document template includes a section for each participant so they can focus on their own specific program responsibilities.

• The REMS@FDA website has been redesigned to prominently display the reorganized REMS document in a way that is easily searchable.

• REMS has been integrated into a Structured Product Labeling (SPL) format to facilitate making REMS information available for existing healthcare systems and workflows. SPL also can be used to capture and present REMS information in a format that is easily shared.

• FDA published a report highlighting best practices for healthcare workers when counseling patients about drugs that require a REMS. This will inform the patient about benefits and risks of the drug, how to mitigate the risks and help them make more informed decisions.

• The agency conducted a feasibility assessment about the use of continuing education credit for training under a REMS and reported the findings, including scenarios for incorporation of CE into REMS programs.

These changes came as a result of FDA’s recently completed REMS Integration Initiative, which started back in 2011, with the goal of developing guidance on how to determine when a REMS is required, improving standardization and assessment of REMS, and better integrating them into the healthcare system.

FDA says it will continue to evaluate REMS and make sure the program is responsive to industry needs, i.e., in part by implementing the REMS Platform Standards Initiative, which included a recent draft guidance on the REMS format and content (template).

Rest assured, the FDA will make every effort to ease the burden of REMS requirements. So patients don’t have to lose sleep about their medication - the FDA’s goal is to maintain patient access while ensuring safe use of a drug.

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